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ISO 14971:2019  is the international standard that defines the lifecycle risk-management process  for medical devices (including SaMD):...

FDA medical device classification determines the regulatory controls required for your device based on risk level. FDA classifies devices...

FDA's new cybersecurity compliance standards carry criminal penalties and RTA threats that can destroy medical device companies. With the...

In FDA device speak, cleared ≠ approved ≠ granted. Mixing these terms can misbrand your product. FDA cleared means 510(k) approval for...

FDA's Safer Technologies Program (STeP)  is a voluntary  program for devices reasonably expected to significantly improve safety  of...

A Software Bill of Materials (SBOM)  is a machine-readable inventory  of every software component in your device—proprietary, OTS, and...

In FDA device world, “ cGMP ” obligations are implemented via the Quality System Regulation (21 CFR 820) . On Feb 2, 2026 , FDA’s Quality...

ISO 13485  is the international QMS standard for medical devices. In the U.S., FDA’s QMSR takes effect Feb 2, 2026 , incorporating ISO...

In 510(k) , substantial equivalence (SE)  means your device has the same intended use  as a predicate  and either the same tech...

An RTA hold  happens when a 510(k)  fails FDA’s acceptance review  and is not accepted  for substantive review; you then have 180 days...

eSTAR  is FDA’s interactive PDF template that structures medical-device submissions in the same layout reviewers use, with built-in...

An FDA Pre-Submission (Q-Sub)  is a voluntary  way to get FDA feedback—by written response and/or a meeting—before or during an IDE,...

An HDE  is a marketing application for a Humanitarian Use Device (HUD) —a device intended to treat/diagnose a condition that affects or...

An Investigational Device Exemption (IDE)  lets an unapproved  or new-use  device be used in a U.S. clinical study to collect...

The FDA Breakthrough Devices Program gives truly novel, life-saving technologies a faster lane through 510(k), De Novo or PMA review. As...

Most SaMD 510(k)s  hit a first-cycle Additional Information (AI) letter , not a final rejection. The recurring issues: missing...

The De Novo  pathway provides marketing authorization  for novel, low–to–moderate-risk  devices without a predicate , creating a new...

Premarket Approval (PMA)  is FDA’s most rigorous pathway, used for most Class III devices  (those that support/sustain life, prevent...

A 510(k) premarket notification  is how most moderate-risk devices show substantial equivalence  to a legally marketed predicate . If...

Choosing an FDA pathway hinges on risk, novelty, and predicates. Use 510(k)  when a suitable predicate exists for the same intended use...